Abstract
Probably the most serious problem facing the field of regenerative medicine today is the challenge of effective translation and development of viable stem cell-based therapies. Particular concerns have been raised over the growing market in unproven cell therapies. In this article, I explore recent developments in the stem cell therapy landscape and argue that while the sale of unproven therapies undoubtedly poses ethical concerns, it must be understood as part of a larger problem at the interface between biomedicine, healthcare, publics, policy and the market. Addressing this will require a broader perspective incorporating the shifting relationships between different stakeholder groups, the global politics of research and innovation, and the evolving role of publics and patients with respect to science.
Highlights
Background/defining the problem The provision of unproven cell therapies continues to be a major ethical challenge in the field of regenerative medicine
From stem cell tourism to trouble at home New tensions are becoming apparent between different stakeholder groups, patients who are seeking to receive treatments and scientists who advocate tighter restrictions on provision
Translational strategies for regenerative medicine? If regenerative medicine is to succeed, it may require the exploration of new translational pathways, given the combination of scientific, social, political and economic factors at play. Reframing the relationships between publics and sciences and their roles with respect to research, innovation and the governance of science may help to navigate the challenges ahead
Summary
HCTPs that are ’minimally manipulated’; ‘intended for homologous use only’ and not combined with ‘another article’ are regulated under s361 of the PHSA (21 CFR 1271.10). They are considered part of the practice of medicine and out with the FDA’s jurisdiction. HCTPs that do not meet these criteria are more strictly regulated, under s351 of the PHSA, as biological drugs requiring premarket evaluation. There is an exception to this for HCTPs that are removed and reimplanted into the same patient during the ‘same surgical procedure’ (21 CFR 1271.15)
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